Sovateltide Dosage Recommendations
The recommended dosage of sovateltide for acute cerebral ischemic stroke is 0.3 μg/kg administered intravenously as a bolus over 1 minute, given three times at 3±1 hour intervals on days 1,3, and 6 after stroke onset. 1
Dosing Protocol
Sovateltide (Tycamzzi™) is administered according to the following protocol:
- Dose: 0.3 μg/kg per administration
- Administration method: Intravenous bolus over 1 minute
- Frequency: 3 doses per treatment day, given at 3±1 hour intervals
- Treatment schedule: Days 1,3, and 6 after stroke onset
- Total daily dose: 0.9 μg/kg/day on treatment days
- Time window for initiation: Within 24 hours of stroke onset
Clinical Evidence Supporting This Dosage
The recommended dosage is based on the most recent and highest quality evidence from a Phase III clinical trial 1, which demonstrated significant efficacy and safety with this regimen. This dosing protocol resulted in:
- 22.67% higher proportion of patients achieving modified Rankin Scale (mRS) scores of 0-2 at day 90 (OR 2.75)
- 17.05% more patients achieving NIHSS scores of 0-5 at day 90 (OR 2.67)
- 72.50% of patients showing improvement of ≥2 points on mRS (compared to 51.28% in control)
Safety Profile
Sovateltide has demonstrated a favorable safety profile at the recommended dosage:
- No drug-related adverse events were reported in clinical trials 2, 1
- Hemodynamic, biochemical, and hematological parameters were not affected by sovateltide administration 2
- The incidence of intracranial hemorrhage was similar between sovateltide and control groups (8.75% vs. 8.97%) 1
Patient Selection Considerations
Sovateltide is indicated for:
- Adult patients aged 18-78 years
- Radiologically confirmed acute cerebral ischemic stroke
- Treatment within 24 hours of stroke onset
- Baseline NIHSS score ≥6
Contraindications
Sovateltide should not be administered to patients with:
- Recurrent stroke
- Intracranial hemorrhage
- Those receiving endovascular therapy
Monitoring Requirements
During administration of sovateltide:
- Monitor vital signs during and after administration
- Assess for potential adverse reactions
- Evaluate neurological status using standardized scales (NIHSS, mRS)
Important Considerations
- Sovateltide should be administered in addition to standard of care for stroke management
- The drug has been approved in India for treatment of cerebral ischemic stroke within 24 hours of onset 3
- The RESPECT-ETB multinational trial is planned for US regulatory approval 1
This dosing regimen has demonstrated significant improvements in neurological outcomes, functional independence, and quality of life in patients with acute cerebral ischemic stroke.